For Gene Therapy -Could be extremely valuable in the diagnosis, treatment, and prevention of diseases -There could be ways in identifying who will develop certain diseases such as cancers, osteoporosis, emphysema, type II diabetes and asthma. -Brings some economic activity through large drug companies, shoestring start- ups, university labs, and government hospitals. -Has already had some successful in correcting immunodeficiency diseases
Against Gene Therapy -Somatic gene therapy doesn’t transfer to offspring. -What is considered a defect and who gets to decide that? -Some think that it would be bad because parents might cross the line between correcting a disease and trying to perfect their child -Experimentation can be dangerous for test subjects – Jesse Gelsinger died.
Web evalution for Source # 1 Josh P. Roberts is the author of the article, which he wrote in June of 2002. This site is an educational resource center (opposing viewpoints). This particular article only presents one side of the argument, the positive advances in gene therapy. However, I do think it was helpful for my research because I needed to find information supporting gene therapy as beneficial and could use other articles (found on the same website) to find information regarding the down side of gene therapy.
LAWYER - Emily -The United States has no federal legislation specifically addressing human genetic modification (either germline and somatic). -All rules that apply to an investigational new drug application (IND) or to support an application for a new drug or biological product. GERMLINE GENETIC MODIFICATION -Dickey-Wicker Amendment- It is illegal to support research “in which human embryos are created, destroyed, discarded, or knowingly be subjected to risk of injury or death greater than allowed for research on fetuses in utero” using federal funds. -The National Institutes of Health has an explicit policy stating that it will not grant for human germline modification. -FDA will require an investigational new drug application (IND) to be filed before the technology may be attempted in humans. -Currently, there are no guidelines or regulations indicating the criteria FDA will use to evaluate such applications.
SOMATIC GENETIC MODIFICATION National Institutes of Health (NIH) -RAC, a public advisory committee of NIH, has a set of federal guidelines addressing the manipulation of genetic material through the use of recombinant DNA techniques (e.g. NIH Guidelines for Research Involving DNA Molecules). -FDA regulates clinical applications of gene therapy based on the authority granted by the Federal Food, Drug and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act). Federal Food and Drug Agency (FDA) -FDA issued a notice in the Federal Register explaining the legal basis for its regulation of gene therapy. It defines gene therapy as “a medical intervention based on modification of the genetic material of living cells” (1993).
Lawyer’s Sources: 1. http://www.dnapolicy.org/policy.international.php?action=detail&laws_id=49
The lawyer's sources were limited. However, this website was able to provide some information in regards to current and future gene therapy laws. While it included many regulations and guidelines, one would not be able to find many specific laws from various states in the United States. There was no known author, as the website is a creation of Johns Hopkins University. Also, the Genetics and Public Policy Center is part of a university, but it is labeled as an organizational website. The article does not appear biased or persuasive. It presents the laws as is. This website was the only source the lawyer was able to find, so I would recommend it to another student despite its lack of detail.
Scientist - Micki What is it? Gene therapy is an experimental technique used in the treatment and prevention of genetic disorders. Genes are carried on chromosomes. Genetic disorders can occur when the proteins that are encoded on the genes are incapable of carrying out their functions. Gene therapy is a method used to correct faulty genes that cause these genetic disorders. Doctors can replace a faulty gene, knock-out a mutated gene, or introduce a new disease fighting gene. How does it work? In most gene therapy cases, a normal gene is inserted into the genome. A vector (or carrier molecule) is used to deliver the new gene into the target cells. According to ornl.gov, “the most common vector is a virus that has been genetically altered to carry normal human DNA”. When the target cells become infected, the vector unloads its genetic material. The generation of a functional protein result from the therapeutic gene reestablishes the target cell to a common state. Retroviruses, adenoviruses, adeno-associated viruses, and herpes-simplex viruses are the most common forms of viruses used as vectors. There are non-viral ways to carry out gene therapy. Direct introduction of new DNA into the target cells has proved to be successful in most cases. However, this method requires large amounts of DNA and can only be used with certain tissues. Another approach involves the creation of an artificial liposome which carries the fresh DNA, and passes it through the target cell’s membrane. Other less-effective systems have been done involving the chemical linking of DNA. Why is it not an effective cure for genetic disorders yet? -The rapidly dividing nature of cells prevents most of the long term cures; patients will have to undergo multiple sessions of gene therapy
- the immune system is designed to attack any foreign objects inserted into the body; makes it hard to repeat gene therapy multiple times
-using viruses as the vector presents several problems: toxicity, immune and inflammatory responses, and gene control and targeting issues; there is always fear that the virus will regain its ability to cause disease again
-many diseases such as Alzheimer’s, arthritis, and diabetes are caused by mistakes on many genes, making gene therapy vary difficult and nearly impossible.
Scientist Web Evaluation:
I gained most of my information from genomics.energy.gov.(number 1 below under "Sources for scientist") It was a government page sponsored by the United States Department of Energy. It provided many links to different questions regarding gene therapy. This page was a sub unit of the human genome project. While there was no specific author, it was compiled by various researches involved in the HGP (Human Genome Project). I found this page very helpful. There was no bias that I could detect, and I found it to be a valuable source of information. The site presented both positives and negatives regarding the topic of gene therapy. I would highly reccomend this site to others doing the same, or similar projects. The site was easy to navigate, and provided a lot of information on the subject. This site was perfect for this project. For more information (Sources for scientist): 1. http://www.ornl.gov/sci/techresources/Human_Genome/medicine/genetherapy.shtml 2. http://ghr.nlm.nih.gov/handbook/therapy/genetherapy 3. http://www.fda.gov/fdac/features/2000/gene.html
What would you do if you could offer these obese boys a gene to increase their metabolism and lose weight fast? Would insert this “perfect” gene to help them get rid of their fat and live a normal life? Or would you let nature take its course? What if these kids have a possibility of dying when they are undergoing this surgery?
What if this was your grandfather, who has a severe case of Alzheimer’s disease? If you could give him a gene that would help restore his lost brain cells, would you? He would not be suffering due to loss of memory. But, would you interfere with “God’s way”. Would you still want him to undergo gene therapy even if he could possibly die from this procedure?
Let’s say you’re a high school football coach and your team is suffering due to lots of strained muscles or torn tendons. A nearby doctor offers to cure these injuries by inserting a perfect gene. But, this would be bringing in a whole different conflict; Sports are supposed to be a test of natural athletic ability. Would you still enhance your athletes since your big championship game is coming up?
Ethical Questions:
How do you personally feel about gene therapy?
What is the definition of “disease”? When is it acceptable to alter someone’s gene? What are proper interventions with our genetic makeup?
Do you believe it is okay for humans to mess around with their genes?
Do you think people are going against the force of nature or even the force of God in changing one’s genes?
Is somatic gene therapy (which is done in the adult cells of persons known to have the disease) more or less ethical than germline gene therapy (which is done in egg and sperm cells and prevents the trait from being passed on to further generations)? Is one correct?
Preliminary attempts at gene therapy are very expensive. Who will have access to these therapies? Who will pay for their use?
What would be improper in terms of our human dignity?
Should gene therapy be allowed at all?
Web Page Evaluation: This web page was written by Michael Behar on July 25th, 2007. This is a medical educational website. This article does not seem biased or very opinionated. It presents the facts and it gives both sides of the argument. It was very effective for my use because it presented examples that helped me formulate my questions (since I was the educator). I would definitely recommend it to someone else because it is detailed and informative.
GENE THERAPY
Sociologist - Caroline
For Gene Therapy
- Could be extremely valuable in the diagnosis, treatment, and prevention of diseases
-There could be ways in identifying who will develop certain diseases such as cancers, osteoporosis, emphysema, type II diabetes and asthma.
- Brings some economic activity through large drug companies, shoestring start- ups, university labs, and government hospitals.
- Has already had some successful in correcting immunodeficiency diseases
Against Gene Therapy
- Somatic gene therapy doesn’t transfer to offspring.
- What is considered a defect and who gets to decide that?
- Some think that it would be bad because parents might cross the line between correcting a disease and trying to perfect their child
- Experimentation can be dangerous for test subjects – Jesse Gelsinger died.
Sources:
Roberts, Josh P. "Gene Therapy Research Has Made Significant Advances." At Issue: Gene Therapy. Ed. Roman Espejo. San Diego: Greenhaven Press, 2005. Opposing Viewpoints Resource Center. Gale. CONESTOGA HIGH SCHOOL. 28 May. 2008 http://find.galegroup.com/ovrc/infomark.do? &contentSet=GSRC &type=retrieve &tabID=T010 &prodId=OVRC &docId=EJ3010323205 &source=gale &srcprod=OVRC &userGroupName=berw2747 &version=1.0.
Human Genome Management Information System. "Gene Therapy: An Overview." At Issue: Gene Therapy. Ed. Roman Espejo. San Diego: Greenhaven Press, 2005. Opposing Viewpoints Resource Center. Gale. CONESTOGA HIGH SCHOOL. 28 May. 2008 http://find.galegroup.com/ovrc/infomark.do? &contentSet=GSRC &type=retrieve &tabID=T010 &prodId=OVRC &docId=EJ3010323202 &source=gale &srcprod=OVRC &userGroupName=berw2747 &version=1.0.
Web evalution for Source # 1
Josh P. Roberts is the author of the article, which he wrote in June of 2002. This site is an educational resource center (opposing viewpoints). This particular article only presents one side of the argument, the positive advances in gene therapy. However, I do think it was helpful for my research because I needed to find information supporting gene therapy as beneficial and could use other articles (found on the same website) to find information regarding the down side of gene therapy.
LAWYER - Emily
- The United States has no federal legislation specifically addressing human genetic modification (either germline and somatic).
- All rules that apply to an investigational new drug application (IND) or to support an application for a new drug or biological product.
GERMLINE GENETIC MODIFICATION
- Dickey-Wicker Amendment- It is illegal to support research “in which human embryos are created, destroyed, discarded, or knowingly be subjected to risk of injury or death greater than allowed for research on fetuses in utero” using federal funds.
- The National Institutes of Health has an explicit policy stating that it will not grant for human germline modification.
- FDA will require an investigational new drug application (IND) to be filed before the technology may be attempted in humans.
- Currently, there are no guidelines or regulations indicating the criteria FDA will use to evaluate such applications.
SOMATIC GENETIC MODIFICATION
National Institutes of Health (NIH)
- RAC, a public advisory committee of NIH, has a set of federal guidelines addressing the manipulation of genetic material through the use of recombinant DNA techniques (e.g. NIH Guidelines for Research Involving DNA Molecules).
- FDA regulates clinical applications of gene therapy based on the authority granted by the Federal Food, Drug and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act).
Federal Food and Drug Agency (FDA)
- FDA issued a notice in the Federal Register explaining the legal basis for its regulation of gene therapy. It defines gene therapy as “a medical intervention based on modification of the genetic material of living cells” (1993).
Lawyer’s Sources:
1. http://www.dnapolicy.org/policy.international.php?action=detail&laws_id=49
The lawyer's sources were limited. However, this website was able to provide some information in regards to current and future gene therapy laws. While it included many regulations and guidelines, one would not be able to find many specific laws from various states in the United States. There was no known author, as the website is a creation of Johns Hopkins University. Also, the Genetics and Public Policy Center is part of a university, but it is labeled as an organizational website. The article does not appear biased or persuasive. It presents the laws as is. This website was the only source the lawyer was able to find, so I would recommend it to another student despite its lack of detail.
Scientist - Micki
What is it?
Gene therapy is an experimental technique used in the treatment and prevention of genetic disorders. Genes are carried on chromosomes. Genetic disorders can occur when the proteins that are encoded on the genes are incapable of carrying out their functions. Gene therapy is a method used to correct faulty genes that cause these genetic disorders. Doctors can replace a faulty gene, knock-out a mutated gene, or introduce a new disease fighting gene.
How does it work?
In most gene therapy cases, a normal gene is inserted into the genome. A vector (or carrier molecule) is used to deliver the new gene into the target cells. According to ornl.gov, “the most common vector is a virus that has been genetically altered to carry normal human DNA”. When the target cells become infected, the vector unloads its genetic material. The generation of a functional protein result from the therapeutic gene reestablishes the target cell to a common state. Retroviruses, adenoviruses, adeno-associated viruses, and herpes-simplex viruses are the most common forms of viruses used as vectors. There are non-viral ways to carry out gene therapy. Direct introduction of new DNA into the target cells has proved to be successful in most cases. However, this method requires large amounts of DNA and can only be used with certain tissues. Another approach involves the creation of an artificial liposome which carries the fresh DNA, and passes it through the target cell’s membrane. Other less-effective systems have been done involving the chemical linking of DNA.
Why is it not an effective cure for genetic disorders yet?
-The rapidly dividing nature of cells prevents most of the long term cures; patients will have to undergo multiple sessions of gene therapy
- the immune system is designed to attack any foreign objects inserted into the body; makes it hard to repeat gene therapy multiple times
-using viruses as the vector presents several problems: toxicity, immune and inflammatory responses, and gene control and targeting issues; there is always fear that the virus will regain its ability to cause disease again
-many diseases such as Alzheimer’s, arthritis, and diabetes are caused by mistakes on many genes, making gene therapy vary difficult and nearly impossible.
Scientist Web Evaluation:
I gained most of my information from genomics.energy.gov.(number 1 below under "Sources for scientist") It was a government page sponsored by the United States Department of Energy. It provided many links to different questions regarding gene therapy. This page was a sub unit of the human genome project. While there was no specific author, it was compiled by various researches involved in the HGP (Human Genome Project). I found this page very helpful. There was no bias that I could detect, and I found it to be a valuable source of information. The site presented both positives and negatives regarding the topic of gene therapy. I would highly reccomend this site to others doing the same, or similar projects. The site was easy to navigate, and provided a lot of information on the subject. This site was perfect for this project.
For more information (Sources for scientist):
1. http://www.ornl.gov/sci/techresources/Human_Genome/medicine/genetherapy.shtml
2. http://ghr.nlm.nih.gov/handbook/therapy/genetherapy
3. http://www.fda.gov/fdac/features/2000/gene.html
MLA Citations for Scientist:
"Gene Therapy." Human Genome Project Information. 13 May 2008. US Department of Energy. 21 May 2008 <http://www.ornl.gov/sci/techresources/Human_Genome/medicine/genetherapy.shtml>.<span style="mso-spacerun: yes">
"What is Gene Therapy." Genetics Home Reference. 25 May 2008. US National Library of Medecine. 28 May 2008 <[[http://ghr.nlm.nih.gov/handbook/therapy/genetherapy%3E.%3C/span%3E%3C/span|http://ghr.nlm.nih.gov/handbook/therapy/genetherapy>.</span]]>
EDUCATOR – Dina
Ethical Questions:
Web Page Evaluation:
This web page was written by Michael Behar on July 25th, 2007. This is a medical educational website. This article does not seem biased or very opinionated. It presents the facts and it gives both sides of the argument. It was very effective for my use because it presented examples that helped me formulate my questions (since I was the educator). I would definitely recommend it to someone else because it is detailed and informative.